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Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies

NCT04521413 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-05-21

No results posted yet for this study

Summary

The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.

Conditions

  • Advanced Solid Malignancies

Interventions

DRUG

CFI-402411

CFI-402411 is administered orally once daily. The starting dose is 80 mg/day for escalation arms and the recommended dose for the expansion arms.

DRUG

Pembrolizumab

Pembrolizumab will be given at its labeled dose and schedule, 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks.

Sponsors & Collaborators

  • TIO Discovery Engine

    collaborator UNKNOWN

  • Treadwell Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Omid Hamid, Dr · The Angeles Clinic, Los Angeles

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2025-11-30
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Hong Kong

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04521413 on ClinicalTrials.gov